EGIS Esophageal Silicone Covered Anti-Reflux Valve Stent

Organization name

SRN

KR-MF-000015781

Manufacturer status

Active

2 warnings recorded — scroll inside the panel to see all entries.

• CW010

  Contraindications for the EGIS Esophageal Stent include, but may not be limited to: • Serious blood clotting disorders • Placement in necrotic chronically bleeding tumors • Placement in polypoid lesions • Extremely narrow and rigid strictures that cannot be dilated to allow passage of the introducer system, guidewire • Patients, with whom endoscopic techniques cannot be performed and/or are contraindicated • Cannot be suited for neonatal, pediatric and adolescent use. • If there is an abscess/perforation in the abdominal cavity • Use other than those specifically presented for intended purposes • Patients with hemorrhagic disease • Suspected perforation or symptoms of perforation are about to appear.
• CW026

  The patients who have implanted this device may be scanned safely on a MRI Environment that satisfies as below: • Static magnetic Field of 1.5-Tesla and 3.0-Tesla • Maximum spatial gradient magnetic field of 3,000 gauss/cm • Maximum MR system reported, whole body averaged specific absorption rate(SAR) of 2 w/kg Additional description Under the above defined scanning conditions, the maximum temperature rise is expected to be less than 3.1℃ when the EGIS Esophageal stent was MRI performed for 15 minutes of scanning. From the non-clinical testing, the distorted image due to the medical device was extended up to 4.0 mm when it was scanned under T1 SE, GRE pulse sequence of 3.0-Tesla MRI

Primary placement in Belgium; available across 2 countries total.

• Batch number
• Expiration date
• Manufacturing date
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• Software identification

European Medical Device Nomenclature — the EU product classification assigned to this device.

• P050199ESOPHAGEAL PROSTHESES - OTHER

• Class IIb medical devices in EUDAMED

No certificate specifically references this device's Basic UDI-DI.